PURPOSE Chemotherapy-induced nausea and vomiting (CINV) is a significant toxicity of chemotherapy. Olanzapine is recommended in adult patients for the prevention of CINV but has not been prospectively investigated in children. METHODS This investigator-initiated, randomized, open-label trial evaluated olanzapine in children (ages 5-18 years) scheduled to receive the first cycle of highly emetogenic chemotherapy (HEC). All participants received aprepitant, ondansetron, and dexamethasone during and 2 days after chemotherapy. Participants in the study group additionally received oral olanzapine 0.14 mg/kg/day (rounded to the nearest 2.5 mg; maximum, 10 mg) during the chemotherapy block and 3 days postchemotherapy. The primary objective was to compare complete response (CR) rates (no vomiting and no rescue medication) between the groups in the acute, delayed, and overall periods. Nausea comparison and safety evaluation were secondary and additional objectives, respectively. The collection of outcomes and adverse events was performed daily until the completion of the overall period. RESULTS A total of 240 patients underwent randomization. We performed a modified intention-to-treat analysis on 231 patients (116 in the control group and 115 in the study group). A higher proportion of patients in the olanzapine group achieved CR in the acute period (78% v 59%; P = .001), delayed period (74% v 47%; P < .001) and overall period (64% v 38%; P < .001) than in the control group. The proportion of patients with no nausea was significantly higher in the olanzapine group in the acute period (74% v 52%; P < .001), delayed period (74% v 47%; P < .001), and overall period (64% v 37%; P < .001). Grade 1/2 somnolence was greater in the olanzapine group (35% v 11%; P < .001). There was no grade 3/4 somnolence reported. CONCLUSION Olanzapine significantly improved CR rates for vomiting in children receiving the first cycle of HEC.

Introduction:Lack of restorative sleep and altered sleep-wake cycle is a frequent problem among patients admitted to the Intensive Care Unit (ICU). This study was conducted to estimate the prevalence of poor sleep and patient's perspective of factors governing poor sleep in the ICU.Materials and Methods:A cross-sectional study was performed in medical ICU of a tertiary care hospital. A total of 32 patients admitted to the ICU for at least 24 h were recruited. A 72-h actigraphy was done followed by a subjective assessment of sleep quality by the Richards-Campbell Sleep Questionnaire (RCSQ). Patient's perspective of sleep quality and quantity and possible risk factors for poor sleep were recorded.Results:Poor sleep (defined as RCSQ <50, sensitivity 88% and specificity 87%) was found in 15 out of the 32 patients (47%). The prevalence of poor sleep was higher among patients on mechanical ventilation (n = 15) (66.7% vs. 33.3%, P < 0.05). Patients with poor sleep had higher age (median age [in years] 42.8 vs. 31.4, P = 0.008), acute physiology, and chronic health evaluation II score (mean 14 ± 5.15 vs. 9.3 ± 5.64, P = 0.02), SAPS 3 score (62.7 ± 8.9 vs. 45.6 ± 10.5, P ≤ 0.0001), and worse actigraphy parameters. Only 55.63% of total sleep time was in the night (2200–0600). All patients had discomfort from indwelling catheters and suctioning of endotracheal tubes. All patients suggested that there be a minimum interruption in the sleep for interventions or medications.Conclusion:There is a high prevalence of poor sleep among patients admitted to the ICU. There is a dire need to minimize untimely interventions and design nonpharmacological techniques to allow patients to sleep comfortably.

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ObjectivesTo assess the cost-effectiveness of addition of olanzapine to a prophylactic antiemetic regimen containing aprepitant, dexamethasone and ondansetron among children receiving highly emetogenic chemotherapy (HEC) in India, Bangladesh, Indonesia, the UK and the USA.MethodsHealth states were estimated using individual patient-level outcome data from a randomised trial. The incremental cost–utility ratio (ICUR), incremental cost-effectiveness ratio and net monetary benefit (NMB) were calculated from the patient perspective for India, Bangladesh, Indonesia, the UK and the USA. One-way sensitivity analysis was done by varying the cost of olanzapine, cost of hospitalisation and utility values by ±25%.ResultsThe olanzapine arm had an increment of 0.0018 quality-adjusted life-years (QALY) over the control arm. The mean total expenditure in the olanzapine arm was greater by US$0.51, US$0.43, US$6.73, US$11.05 and US$12.35 in India, Bangladesh, Indonesia, the UK and the USA, respectively. The ICUR($/QALY) was US$282.60 in India, US$241.42 in Bangladesh, US$3755.93 in Indonesia, US$6161.83 in the UK and US$6887.41 in the USA. The NMB was US$9.86, US$10.12, US$14.08, US$44.74 and US$98.79 for India, Bangladesh, Indonesia, the UK and the USA, respectively. The ICUR estimates of the base case and sensitivity analysis were below the willingness-to-pay threshold in all scenarios.ConclusionThe addition of olanzapine as a fourth agent for antiemetic prophylaxis is cost-effective despite an increase in overall expenditure. Olanzapine should be uniformly considered for children receiving HEC.

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7014 Background: Acute myeloid leukemia (AML) is a heterogeneous disease. Improvement in supportive care, has considerably improved AML induction outcomes, decreasing induction deaths to <5% in recent studies. However, induction deaths during AML treatment in resource constraint settings remains as high as 25% in young adults. In this study we explore various challenges encountered in treating AML patients in one of the largest public sector teaching hospitals in India. Methods: Consecutive patients diagnosed with AML and registered in our clinic from January 1, 2018 to December 31, 2019, were included. Results: Of 316 patients diagnosed with AML, only 181 (57%) were able to get admitted to our institute for remission induction treatment. Median time from diagnosis to treatment initiation was 9.5 days (range, 0-232 days). Almost half (N=88; 49%) of admitted patients had infections at the time of admission. Among these, 31 (35%) had invasive fungal infection; 14 possible, 15 probable, and 2 proven. Fifty-two (29%) patients died prior to starting their remission induction therapy. Induction mortality in our cohort is 40%. Primary induction failure and primary refractory disease were noted in twenty (18%), and 5 (4%) patients respectively. Only 1 patient was able to get all three high dose cytarabine (HIDAC) consolidations on time. Median time to first HIDAC was 39.5 days (range, 28-91). Of 83 patients who were candidates for consolidative allogeneic hematopoietic cell transplantation (HCT), only ten (12%) patients were able to get transplanted. Median time to HCT from CR1 was 3.8 months (range, 1.89-12.8). The median event free survival (EFS) was 1.7 months (95%CI, 1.03-2.5) and median overall survival was 2.5 months (95%CI, 1.6-3.6). The median EFS in favourable risk, intermediate risk and adverse risk AML was 3.6 months, 3.7 months, and 3.4 months respectively. Likewise the median OS was 8.8 months, 11.8 months and 7.4 months in the three risk strata respectively. Conclusions: Outcomes of AML treatment in our cohort are discordant with that reported from the West. Our study identifies various challenges in treating AML in resource-constraint setting. Strategies need to be formulated to overcome these challenges. [Table: see text]

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